- Cytiva (Miami, FL)
- …and other functions, and facilitate risk-based decisions.Prepare, update and review regulatory support documentation, including Validation Guides, statements, ... about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …protocols, reports and SOPs in support of the stability program, including review and implementation of regulatory requirements for the stability ... off-site laboratory facilities (as needed).Ensure data is evaluated, including the creation, review and trending of data, to meet customer, industry and … more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This position is part of the Global Quality System and Compliance Group ... Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of issues while… more
- Aldevron (New York, NY)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.This is a remote position...control mechanisms, such as document control, change management, and review cycles, to maintain labeling integrity.Collaborate with internal stakeholders:… more
- Cytiva (Miami, FL)
- …as related to compliance with internal and external quality and regulatory standards. Assist with the implementation of standard operating procedures to ... to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO… more
- Pall (Miami, FL)
- …quality assurance tests to ensure product specifications are met. May review , investigate, resolve, and report on quality discrepancies. May develop, maintain, ... for ensuring all incoming products meet technical, quality specifications and regulatory requirements.Develop the strategy and execute on a proactive risk-based… more
- Cepheid (Miami, FL)
- …maintained in a high state of compliance.Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by the ... Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals.Evaluation, acquisition, and implementation… more
- JPMorgan Chase (Columbus, OH)
- …issues from strategy to execution. As a Vice President in the Home Lending- Marketing Regulatory Review team, you will serve as a subject matter expert for all ... find a talented professional who will be responsible for compliance/ regulatory reviews of marketing materials/communications across various marketing channels. This… more
- US Bank (St. Paul, MN)
- …career with us** US Bank is hiring multiple positions as a **Business Line Regulatory Review Representative** to support our _Fiduciary Review Group (FRG) ... days remote **Location** : West Side Flats Saint Paul, MN **Business Line Regulatory Review Representative 6** **_Basic Qualifications_** + Bachelor's degree, or… more
- Grant Thornton (Charlotte, NC)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, and ... day-to-day may include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's regulators + Conducting… more
- City of New York (New York, NY)
- …Essential Duties and responsibilities: This rotation will introduce interns to the project review process in the BWSO Drilling and Excavation Section with respect to ... be measured by performing engineering work and assists supervisor/manager with the review of engineering proposals submitted by other agencies to determine the… more
- City of New York (New York, NY)
- …The NYC Department of Environmental Protection (DEP) enriches the environment and protects public health for all New Yorkers by providing 1.1 billion gallons of high ... quality drinking water, managing wastewater and stormwater, and reducing air, noise, and hazardous materials pollution. DEP is the largest combined municipal water and wastewater utility in the country, with nearly 6,000 employees. DEP's water supply system is… more
- Abbott (Abbott Park, IL)
- …Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review . Monitor and submit applicable reports to ... ensure regulatory compliance. Assess external communications relative to regulations. Review regulatory aspects of contracts. Assist with label development… more
- Takeda Pharmaceuticals (Boston, MA)
- … Advisor and function as the "R" in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). ... to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is… more
- Merck (Annapolis, MD)
- …agencies and/or subsidiaries for all applications and submissions and be responsible for regulatory review and final approval for all submissions and associated ... approval by agencies for conduct of clinical trials. + Participate in regulatory due diligence activities for licensing candidate review **Minimum Education… more
- Abbott (Santa Clara, CA)
- …Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to ... post-marketing approval requirements. + Assess external communications relative to regulations. + Review regulatory aspects of contracts. + Assist with label… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic products ... Affairs. **Responsibilities:** + Lead, develop, and mentor a team of regulatory advertising and promotion professionals, including a Review team, and… more
- Teleflex (Chelmsford, MA)
- …risk activities as well as other deliverables as related to projects. * Provide regulatory review for reporting activities required by EU MDR (ie post-market ... and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development… more
- Abbott (Plymouth, MN)
- …submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders. ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities. + Evaluate… more
